“responding to the pandemic together” programme episode 25: … · 2020-07-23 · welcome to...
TRANSCRIPT
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“Responding to the Pandemic Together” Programme
Episode 25:
Medicine Supply Disruptions and Shortages
during the PandemicDelivered by the FIP Young Pharmacists Group, FIP Industrial Pharmacy Section,
FIP Drug Delivery and Manufacturing SIG
July 22, 2020 16:00 CEST
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Facilitators
Clement Haeck, PharmD, MSc, PhD
FIP YPG Drug Delivery and Manufacturing SIG Liaison
(France)
Gerard Lee L. See, RPh, MSc, PhD, SRPharmS
FIP YPG Industrial Pharmacy Section Liaison
YPG-Cebu Chapter President
(Philippines)
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I. Provide relevant information and interim guidelines for pharmacists and the pharmacy workforce on
Coronavirus SARS-CoV-2/COVID-19 pandemic.
II. Share and discuss strategies adopted by pharmacy leaders and workers - including our Member
Organisations – in response to the pandemic.
III. Describe sector or area-specific implications, innovations and approaches adopted across pharmaceutical
science, practice and education.
IV. Engage frontline workers of the health and pharmacy workforce to know about the realities facing them
around the world.
V. Discuss the implications of the pandemic on issues such as safety, supply, shortages that have been
exacerbated by COVID-19, across our nations and regions.
VI. Consider the impact of this disease on patients across age groups and with concurrent conditions.
VII. Assess and discuss the evidence behind treatments and the process of developing therapies, vaccines and
tests.
Welcome to the “Responding to the Pandemic Together” events
FIP’s Special Online Programme on COVID-19
These webinars aim to:
To share ideas on webinar topics we should feature, or if
you’d like to share your story on dealing with the pandemic
please email
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Important Links & Resources
FIP Covid-19 Information Hub
A comprehensive FIP webpage containing all of our
resources and outputs relating to COVID-19, including
recordings of previous webinars.
Link: https://www.fip.org/coronavirus
FIP Facebook Group: “COVID-19 & pharmacy”
Link:
https://www.facebook.com/groups/covid19andpharmacy/
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Announcements
1. This webinar is being recorded and live streamed on Facebook
2. The recording will be freely available at www.fip.org/coronavirus and
on our YouTube channel
3. You may ask questions by typing them into the Q&A box
4. Your feedback is welcome ([email protected])
FIP Digital Events House Rules
©FIP: All the information in this video are confidential and cannot be copied,
downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Learning Objectives
• Describe the differences between supply disruptions, low stocks, and
shortages
• List the main medicine and healthcare products affected
• Explain the potential impact of these issues
• Outline different strategies developed to face these problems in different
regions and countries
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Event Chair/Moderator
Ulf Janzon, MSc
President, Swedish Pharmacists Association
President, FIP Industrial Pharmacy Section
(Sweden)
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Speaker 1
Propser Hiag, PhD
• International Pharmaceutical consultant
• Social entrepreneur and advocate for quality drugs access in
Africa and WHO Good Manufacturing Practices for drugs
conception and promoter of local drugs manufacturing in Africa
• Council Member of FIP
• President of African Pharmaceutical Forum
• President of Cameroon National Pharmaceutical Society
(CNOPC)
(Cameroon)
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Medicines Supply Disruption and Shortages during the COVID-19 Pandemic in Africa
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Main points to be highlighted here
1. Statement on the potential reasons for the disruption and
shortages in the Africa region
2. Introduction of actions taken by governments and
organizations to face these challenges.
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Overview
• COVID-19 pandemic has caused massive disruptions to global supply
chains.
• In Africa between 70% and 90% of Drugs are imported
• Significant shortages of other essential medicines can be materialize.
• Rise in substandard and falsified products related to fight against COVID-
19.
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Some shortages area
• Hydroxychloroquine
• Chloroquine
• Azithromycin
• Dexamethasone
• ARV
• Insulin
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Reasons for the disruption and shortages (1)
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
• Lack of manufacturing capacity
• Shortage of raw materials
• Political instability
• Absence of national contracts on the regional code lists of medicines
• Failure of suppliers to meet demand and the failure to pay suppliers
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• The buy-out process not structure
• Suppliers not performing
• The inaccuracy of the electronic inventory
management system.
• Manufacturing and quality problems
• Production delays
Reasons for the disruption and shortages (2)
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Actions taken by decision makers (1)
• Produce quality-assured, essential pharmaceutical products locally
• Ethiopia and South Africa have developed national strategies and
manufacturing roadmaps (to address financial barriers and
improve quality)
• South Africa and Egypt are beginning to produce active ingredients
locally
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Actions taken by decision makers (2)
• In Nigeria, the Central Bank of Nigeria, is working to stimulate the sector by
extending lines of credit to local manufacturers
• Afrexim Bank, the UN Economic Commission for Africa (UNECA), and the
African Center for Disease Control recently announced emergency
interventions to rapidly respond to supply and policy gaps
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downloaded or reproduced without the formal approval of FIP (International
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Actions taken by decision makers (3)
• South Africa, Ongoing monitoring for the future use of computerized inventory
management systems is important to reduce medicines shortages, and this is
being followed up.
• In Cameroon, the government empower and encourage local production of
Hydroxychloroquine.
• UNECA, the Federation of African Pharmaceutical Manufacturers Associations
(FAPMA), and the WHO
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Actions taken by decision makers (4)
• The African Medicines Agency (AMA), a
continental effort to harmonize medicines
regulation
• Integration of herbal medicines and Traditional
medicines
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Conclusion
• Scaling up African pharmaceutical capacity will help to provide sustainable
access to quality medical products and increase health security during the
COVID-19 pandemic and beyond.
• African countries should improve cooperation and trade within the continent.
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Speaker 2
Joan Alexis Sepulveda Mora
Member, Board of Directors of the National
Board of Pharmaceutical Chemists of Colombia
(Colombia)
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Colombia: as a case study in the Americas Region
21
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1. Colombia: as a case study
2. General measures to prevent shortages of supplies and other
disinfection elements
3. Measures to prevent the shortage of drugs for symptomatic
treatment
4. Measures to prevent the shortage of medicines necessary for
treatment in intensive care units
5. General conclusions
22
Overview
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Pharmaceutical Federation).
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• An upper middle-income economy, member of the OECD
since April 28, 2020.
• The health system in Colombia is part of the Colombian Social
Security System regulated by the Government of Colombia
• The country has a national regulatory agency (NRA) that
approves the marketing of all products that have an impact on
public health.
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copied, downloaded or reproduced without the formal approval of FIP
(International Pharmaceutical Federation).
23
Colombia: as a case study
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• the basic elements for the prevention of virus
transmission traditionally in Colombia are classified
into several categories according to the regulatory
authority: hydroalcoholic solutions for hand disinfection
are classified as drugs if they have more than 70%
ethanol or as cosmetics if they have a percentage of
ethanol between 60 and 69%, meanwhile, facial masks
are classified as medical devices.
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copied, downloaded or reproduced without the formal approval of FIP
(International Pharmaceutical Federation).
24
General measures to prevent shortages of supplies and other disinfection elements
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• In general terms, the ANR reduced the conditions so
that disinfectant and protection products could be
marketed, changing the marketing authorization
called sanitary registration or sanitary notification as
the case may be and allowing marketing with a
temporary permit.
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copied, downloaded or reproduced without the formal approval of FIP
(International Pharmaceutical Federation).
25
General measures to prevent shortages of supplies and other disinfection elements
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• Ministry of Health and Social Protection at the moment, a specific treatment for any coronavirus is not
recommended, so the treatment of covid-19 is symptomatic.
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copied, downloaded or reproduced without the formal approval of FIP
(International Pharmaceutical Federation).
26
Measures to prevent the shortage of drugs for symptomatic treatment
• Recommendations focus on trying to reduce social interaction as much as possible and, in case of
symptoms, isolate yourself voluntarily, request that the test be carried out and maintain treatment at
home for as long as possible.
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• The primary measure established by the national
government is through the NRA to expedite the
approval processes for the initiation of clinical studies
of new or known chemical entities for the specific
indication, at this time studies on Remdesivir, plasma
and the clinical study " Solidarity "of the WHO, are
being carried out in the country
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copied, downloaded or reproduced without the formal approval of FIP
(International Pharmaceutical Federation).
27
Measures to prevent the shortage of drugs for symptomatic treatment
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• All the medicines necessary for the treatment of patients with COVID 19 were included in a positive list
and will be considered in the same way as the medicines for neglected diseases (better known in
Colombia as orphan diseases), which basically simplifies the import procedures of these medications,
accelerating their entry into the country
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copied, downloaded or reproduced without the formal approval of FIP
(International Pharmaceutical Federation).
28
Measures to prevent the shortage of medicines necessary for treatment in intensive care units
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• The national government has taken early measures to prevent the shortage of medicines, however,
Colombia, like other countries in the region, does not have the capacity to self-supply, because although
it has some capacity to produce a finished product (medicine), it does not produce raw materials or active
pharmaceutical ingredients, so the country's ability to meet the need for drugs always depends to a
greater or lesser extent on import processes
• Decrease the regulatory requirements for the commercialization of the products necessary to reduce the
spread of COVID 19 although it can help to increase the offer of this type of products, it can put users at
risk by lowering the quality standards of the products that are market
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copied, downloaded or reproduced without the formal approval of FIP
(International Pharmaceutical Federation).
29
General conclusions
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Speaker 3
J. Jayaseelan
Chairman, Indian Pharmaceutical Association –
Industrial Pharmacy Division
(India)
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Medicines Supply Disruption and Shortages during the COVID-19 Pandemic in South-East Asia (India)
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Indian Pharmaceutical Association
President
Industrial
Pharmacy
Division
Education
Division
Hospital
Pharmacy
Division
Community
Pharmacy
Division
Regulatory
Affairs
Division
J. Jayaseelan
Chairman
The Indian Pharmaceutical Association (IPA) founded in 1939, is the oldest premier association of
pharmaceutical professionals in India, with a member base of over 13,000, spread across the length
and breadth of the nation. IPA operates in India through 20 state branches and more than 46 local
branches.
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Global Impact – Covid 19
Unprecedented
Impacts on Economy Steep rise in
unemployment across
the Globe
Indian
Pharmaceutical
Association
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Effects on Health Care Systems
Indian
Pharmaceutical
Association
• Prioritization and increase of hospital space
• New protocol emerged for treatment
• Sudden importance for Siddha and Ayurveda
• More focus on prevention and immunity boosting
• Rapid Regulatory Changes
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Effects on Health Care Systems
• Invention of new medicines and vaccines
• Preparedness for pandemic / next wave
• Budget restrictions on insurance / Government / Individual
• Emerging of Virtual management of healthcare
• Doctor Patient communication collapsed and
emergence of tele medicine.
Indian
Pharmaceutical
Association
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Global Supply Chain Affected
• Impact on India / China
• Transportation, import and Logistics cost increased to new
height.
• Thin Margins.
• Customers not accepting any Cost Increase.
• Major Supply chain disrupted
• Affected Clinical Trial Landscape
Indian
Pharmaceutical
Association
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Pharmaceutical Federation).
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3rd Largest Producer of Medicines by Volume in the World
Largest Exporter of Medicine
10% volume
Share of world’s total pharma output
Export to 200Countries
Indian Pharma Industry –
The Pharmacy of the World
Indian
Pharmaceutical
Association
2nd
Every
Vaccine
Recognized as global leader in supply of generic
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Covid-19
• China is leader in API
• India imports almost 68 per cent of its API consumption by
value from China
• Highly reliant on China for fermentation-based APIs
(antibiotics) and many key starting materials
• China has the advantage of cost competitiveness through
value-chain integrated clusters, low-cost utilities, high capacity
utilization and economies of scale
Indian
Pharmaceutical
Association
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Medicine Disruption
Manufacturing
Dispensing
Indian
Pharmaceutical
Association
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Manufacturing
• Lockdown issues
• Supporting industries closure
• Logistics breakdown
Depending on China
Indian
Pharmaceutical
Association
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Indian
Pharmaceutical
AssociationMarketing
• Doctors, Nurses, Hospitals, Clinics closed during lockdown
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Pharmaceutical Federation).
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Distribution
Export –
Restrictions on Export / Import
Domestic
Indian
Pharmaceutical
Association
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Pharmaceutical Federation).
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Dispensing - Shortages
Immunity Boosters
A New Segment evolved
A C U T E
T H E R A P Y
M E D I C I N E S
M E D I C I N E S
Indian
Pharmaceutical
Association
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Pharmaceutical Federation).
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Challenges Ahead
• Continues Lockdown created lot of back log.
• Normal processes wont work
• Access and affordability are the Key.
• Controlling Transport and logistic cost
• New ways of working are essential.
• Flexibility in R&D , Regulatory, Marketing ,etc..
• Digital adaption and remote working.
Indian
Pharmaceutical
Association
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
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Speaker 4
Joao Ferreira
Scientific Officer,
European Medicines Agency (EMA)
(The Netherlands)
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Securing availability of medicines across the EU
European response to medicine shortages during the COVID-19 pandemic
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Background: How does the EU manage shortages?
Improving the availability of medicines authorised in the EU is a key priority for the European Medicines
Regulatory Network. In the EU, most medicine shortages are dealt with at national level by national competent
authorities.
In December 2016, a joint HMA/EMA Task Force on the Availability of Authorised Medicines for Human and
Veterinary Use was established in order to provide strategic support and advice to tackle disruptions in supply of
human and veterinary medicines and ensure their continued availability.
In April 2019, the task force established a EU single point of contact (SPOC) network to improve information
sharing between EU Member States, EMA and the European Commission (EC) on shortages of critical human and
veterinary medicines. 47
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48
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
• Temporary lockdowns of manufacturing sites
• Travel restrictions impacting exports
• Export bans
• Increased demand for medicines used to treat COVID-19 patients
• Stockpiling by hospitals, by individual citizens or at Member State level.
Main shortage root causes in the context of the
COVID-19 pandemic
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
Responding to the COVID-19
pandemic
EU Executive Steering Group on shortages of medicines caused by major events
• Strategic leadership and EU coordinated actions
• Prevent and mitigate supply disruptions
i-SPOC reporting system between industry and EU regulatory authorities
• Fast-track shortage monitoring system
• Data collection on supply disruptions (and their causes) in relation to COVID-19 medicines (ICU setting)
EU Single point of contact (SPOC) network
• Gathered information on COVID-19 medicines (ICU setting) on shortages
• Collected demand data from EU MSs for 14 APIs under export restrictions (India)
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downloaded or reproduced without the formal approval of FIP (International
Pharmaceutical Federation).
Any questions?
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Send us a question Go to www.ema.europa.eu/contact
Telephone +31 (0)88 781 6000
Further information
Follow us on @EMA_News
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Question Time
Please use the chat
board to log your
questions & comments.
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